Field of the Application
The application relates generally to spray drying pharmaceuticals, and particularly to a method for preparing spray dried vancomycin.
Description of Related Art
Vancomycin Hydrochloride (HCl) (C66H75Cl2N9O24.HCl, molecular weight 1485.71) is an injectable antibiotic that is used to fight susceptible bacteria that cause infections in the body. Vancomycin HCl is typically provided in a powdered form to a health care provider. For example, Vancomycin HCl for Injection (Hospira, Inc., Lake Forest, Ill.) is a sterile dry mixture of vancomycin HCl and may contain a suitable stabilizing agent. Vancomycin HCl is generally prepared into its powdered form by lyophilizing (freeze-drying) an aseptically filled solution of vancomycin HCl in water. The lyophilization process can be inefficient and require expensive production equipment and processing steps.
As an alternative to lyophilization, spray drying involves transformation of a formulation from a fluid state into a dried form by spraying the formulation into a hot drying medium. The formulation can be either a solution, suspension, or a paste. The spray dried product is typically in the form of a powder consisting of single particles or agglomerates, depending upon the physical and chemical properties of the formulation and the dryer design and operation. The basic technique includes the following four steps: a) atomization of the formulation solution into a spray; b) spray-gas contact; c) drying of the spray; and d) separation of the dried product from the drying gas. An aseptic spray drying method can be a more efficient and cost effective process of powder generation compared to lyophilization.
Accordingly, the inventors have identified a need in the art for a suitable formulation and process for spray drying vancomycin.